Time of Treatment in HALL Technique Vs ART

NCT06594770 | Not Yet Recruiting

• 1 other identifier: Hall technique VS ART
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to assess the time of treatment of Hall Technique versus Atraumatic Restorative Technique in the management of carious primary molars. The main questions it aims to answer are:

• Does the Hall Technique provide a faster and pain-free treatment compared to ART?
• How do the outcomes of both techniques impact children's acceptance and behavior? Researchers will compare the Hall Technique, which uses preformed metal crowns without caries removal, to Atraumatic Restorative Treatment, which uses hand instruments to selectively remove carious tissue. Participants will:
• Receive treatment using either the Hall Technique or ART in a single session.
• Attend follow-up visits to monitor the effectiveness and acceptance of the treatment.
• Complete assessments on their experience and comfort during and after the procedure.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• time of treatment

  Time will be measured from the start of the procedure till its end using digital chronometer as a device and minutes as a unit.

  during the procedure

Secondary Outcomes (4)

• Postoperative Pain and discomfort

  immediately after the procedure , 3month ,6 month and 12 month

• Child behavior

  during the procedure

• Canine overbite: HT

  preoperatively , immediately after the procedure , 3 month , 6 month, 12 month

• Child anxiety

  during the procedure

Study Arms (2)

ART

EXPERIMENTAL

Procedure: Atraumatic Restorative Treatment

HALL technique

ACTIVE COMPARATOR

Procedure: Hall technique

Interventions

Atraumatic Restorative Treatment PROCEDURE

A sharp excavator will be used to remove soft demineralized carious tissue from the patient\'s primary molar 2-The molar will then be restored with capsulated Glass Ionomer in accordance to ART procedure. 3-Each capsule will be mixed for ten seconds and used for restoring teeth isolated by cotton rolls. 4-After the cement is cured, excess material will be removed with an excavator and a carver. 5-The occlusion will be tested for interferences with carbon paper. A layer of varnish coat will be applied to the surface and light-cured for 20 seconds .

ART

Hall technique PROCEDURE

The procedure involves assessing the occlusion, contact points, and tooth shape. If contact points are present, orthodontic separators will be placed between the primary molars to create space for crown fitting, with the child seated upright to maintain airway safety. After 3 to 5 days, the separators will be removed, and loose plaque and debris will be cleared. The correct crown size will be selected, ensuring it doesn't impinge on adjacent teeth, and will be filled with glass ionomer cement. The child will be instructed to bite down for two minutes to ensure proper seating. Excess cement will be removed, and contacts will be flossed. Any initial occlusal discrepancies are expected to resolve within weeks.

HALL technique

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age: From 4 to 6 years.
• Caries in primary molars within enamel/dentin with vital pulp.
• Healthy children.
• Cooperative children

You may not qualify if:

• Presence of signs and symptoms of necrosis.
• Root caries.
• History of spontaneous pain.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Dental Atraumatic Restorative Treatment

Intervention Hierarchy (Ancestors)

Dentistry

Central Study Contacts

Doaa mohamed mustafa

CONTACT

00201550150989; doaa.mustafa@dentistry.cu.eud.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10